“When Emily developed ME, she was tested for all sorts of things to make sure there was no other underlying illness.

“But at no time was she ever tested for coeliac disease.”

So the fact is that Emily did not have M.E. and she never had. She had coeliac disease and it was not cured by the lightning process even though 3 years earlier Rantzen had claimed that her daughter was cured. Emily was actually cured by not eating any gluten.

And that is how the lightning process ‘works’. It is pure quackery which exploits the placebo-effect, coerces ‘patients’ into claiming that they are cured and incidentally, makes money for its ‘practitioners’. Some people will remember Ester Rantzen from ‘That’s Life’, a TV programme which often exposed quackery, fraud and other malpractice. But even she was taken in. Had Emily not remained ill and continued to search for the cause of her illness, she would still be ill today with coeliac disease.

On Monday 17 October 2016, after three and a half years of incarceration, Karina finally returned home to her family. The arrangement was on a trial basis but in the hope and expectation that she would be finally and permanently back where she belongs.

In recent weeks, Karina’s condition had improved slightly and her parents were able to visit her on a regular basis (more detail in my previous post). As a result, meetings took place between those in charge of the Clinic at Hammel where she had been an inmate since February 2013 (see Karina’s Story below for background) and representatives of Karina’s family. An arrangement for Karina’s return home was agreed whereby her parents would take her home within the next few days and she would remain there for a trial period. If all went well…

Changing the Protocol to admit less severely ill patients was rather desperate. But then concocting the outcome measure ‘Normal Range’ which meant that some participants had recovered before they started, has made a laughing-stock of the PACE Trial. But what did it do to the data? Actually, it is not dreadful, but then again, it is not science. Splitting the treatment groups into ‘legal’ and ‘illegal’ participants illustrates the difference between them. Participants are ‘legal’ if their baseline score is BELOW the threshold of ‘Normal Range’ (60). They are ‘illegal’ if their baseline is equal to or above that score – because, well, you just can’t do that! It’s DUMB.

CBT group SF36PF

CBT group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=20:

i.e., already ‘Normal Range’

Legal Participants

Illegal Participants

Baseline Average = 36

Baseline Average = 62

Outcome Average = 56

Outcome Average = 75

The ‘illegal’ CBT participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
80% scored 60 or more and were ‘Normal Range’
60% scored 75 or more and were ‘Improved’ as per the Protocol
45% scored 85 or more and were ‘Recovered’ as per the Protocol

SMC group SF36PF

SMC group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=22:

i.e., already ‘Normal Range’

Baseline Average = 34

Baseline Average = 62

Outcome Average = 47

Outcome Average = 71

The ‘illegal’ SMC participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
82% scored 60 or more and were Normal Range
50% scored 75 or more and were ‘Improved’ as per the Protocol
23% scored 85 or more and were ‘Recovered’ as per the Protocol

Conclusion

The incredible blunder of positioning an outcome threshold BELOW the level required for participation has had an effect on the outcome. The overall influence has been limited due to the Control Group, but in a Trial where the researchers were evidently scrabbling for a few points here and there, the influence has significance.

The PACE Trail Protocol states:“We propose that a clinically important difference would be between 2 and 3 times the improvement rate of SSMC.”

The chart below shows actual, individual CHANGES between baseline (start of the trial) and the 52 week Outcome for 148 participants in the CBT and SMC groups. Added, are CHANGES in the SMC (Control Group) multiplied by 2 (blue) and 3 (green). These show the difference expected by the researchers. If CBT had been effective, the red line would be between or above the blue and green lines at all points.

CBT failed in the PACE Trial – the data proves it. No torture was involved, I politely asked the data whether CBT lived-up to White et al’s expectations. It did not come close. The only way to claim a treatment-effect from these outcomes is by denying the data.

The dark-red dot vertically aligned shows that same participant’s OUTCOME at 52 WEEKS.

A LOWER score means LESS fatigue. An effective treatment for fatigue would have the majority of red dots scoring 12 or lower. It should also have many times more dots at this level than the Control Group (SMC).

The chart below shows the corresponding CFQ Baseline (yellow) CFQ Outcome (green) and SF36PF (red dots) for each participant in the CBT group. There is little correlation between CFQ baseline and outcome or with the SF36PF. The data is so random that no reliable or consistent influence could produce these results. This is a NULL treatment-effect.

“[£200,000] is what this person suffering from a hereditary defect costs the People’s community during his lifetime. Fellow citizen, that is your money too.”

Sioux Blair-Jordan outside the conference, from the East Anglia Daily Times.

In the midst of the most controversial Labour Conference in recent times, the speeches were pored over for things to be outraged about. The country needed to show that the Party had been taken over by ‘lefty loonies’ and, while the big names got front page headlines, other speakers became easy targets. One of these was Sioux Blair-Jordan, a Labour disability rights campaigner, who gave a powerful speech about the dehumanising narrative regarding sickness and disability emanating from the government, and the risks disabled people face if the Conservative Government follows through on their campaign pledge to dissolve the power of the European Court of Human Rights in the UK. The media and commentariat exploded with…

One could be forgiven for wondering if M.E. patients and PACE Trial participants have any right to respect for their autonomy. The PACE authors seem to have no such respect. Collecting information about people then publicly misrepresenting them is not showing respect.

Reading the PACE Trial documents, from the Protocol to the Lancet publication, disregard for participant autonomy seems pervasive and could even be considered inevitable considering espoused theories of the PACE researchers. To whit: ‘participants are so incompetent that they cannot even judge their own health or tell whether they are ill or not, if they could, then a bit of exercise and positive thinking would cure them’. So working from this view of participants as incompetent, it is no surprise that the researchers attitude towards participants was one of condescension verging on abuse.

Just one instance of this disrespect occurred in a Participant Newsletter and is neatly analysed by Hooper and Williams in Magical Medicine. The dubious tactic of employing participants as recruitment officers for the Trial, is not only coercive of the participants, but also risks skewing the data of what was supposed to be a scientific experiment. The PACE researchers stopped short of offering a set of steak-knives for each new recruit introduced, or a skiing holiday for the one that got the most new participants, but the principal is not dissimilar.

The PACE Participants’ Newsletter (Issue 2, March 2007) was openly soliciting for more participants: “If you know of any friends or family who suffer from CFS/ME and who might be eligible and interested in taking part in the study and live close enough to one of these centres, please suggest they approach their GP for a referral to a PACE centre”. The problems with using existing participants to recruit new participants are obvious.

First, the existing participant might no longer feel inclined to report negative effects and might exaggerate any positive effects because (i) they may feel they have become part of the PACE research team and thus feel a loyalty that could influence how they report their experience and (ii) participants who recruit others are asking them to join in their own experience and thus they assume a burden of responsibility, as a result of which they may be less likely to report ‘it was awful’ or ‘ it did not help’. This could render their own subjective data invalid. Furthermore, if a participant knows s/he has persuaded someone else to join the trial, the recruiting participant might no longer feel s/he had the right to drop out or withdraw consent at any time of their choice.

Secondly, a participant who was recruited by a friend or family might also feel similar obligations of loyalty to their friend or family member, so their own data might also be unreliable.

Thirdly, only participants who are enjoying or benefiting from their participation are likely to have recruited others, with the result that a potential participant is exposed to a positive viewpoint that might not adequately reflect the risks and burdens of participation, as well as arousing fears that they are missing out on something helpful. This could be viewed as making unjustifiable claims about the therapies on trial (which could be in breach of the GMC’s Guidelines for Good Medical Practice (section 61) that states: “You must not make unjustifiable claims about the quality or outcomes of your services in any information you provide to patients. It must not…exploit patients’ vulnerability or lack of medical knowledge”).

Fourthly, participants who do not recruit anyone might be influenced by the suggestion that they should recruit and may feel guilty if they are unable to recruit more participants, with the result that they may compensate by being ‘better’ (ie. more positive and less critical) participants. This could affect they way they report their experience and thus invalidate their data.

Other institutions concerned with research integrity require approval for all methods of advertisement prior to use and they consider “advertising or soliciting for study participants to be the start of the informed consent process…Advertisements must be reviewed and approved…When advertising is to be used, the information contained in the advertisement and the mode of its communication (must be reviewed) to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favourable outcome” (http://orip.syr.edu/sop/sop036.php ).

The tactics used for recruitment to the PACE trial seem to indicate the difficulties encountered by the Investigators, a fact that is believed by many people ought to have raised concern with the various ethics bodies.

It is believed that the difficulty in recruitment may have resulted in coercion of sick people.

After long opposition (and substantial expense) from the trial investigators and Queen Mary University of London, data from the £5m publicly funded PACE Trial, which studied graded exercise (GET) and CBT therapies for ME/CFS, has finally been released under the Freedom of Information Act. ME patients Alem Matthees, Tom Kindlon and Carly Maryhew, with the support of two prominent US statisticians, have reanalysed the data according to the original trial protocol and illustrated that the recovery results were exaggerated by a factor of four due to unexplained protocol changes. The revised results were in fact statistically insignificant. This means that , in spite of what the investigators claimed, the trial provided no proof that GET and CBT help people with ME/CFS to recover.

Though those who have studied the trial have long suspected that the results as originally presented were grossly misleading, it is still a “gosh- wow” moment…

Spinning the Results to the Media

On Feb 17th 2011, the Science Media Centre (ScMC) hosted a press conference for the publication of the PACE Trial in the Lancet. The ScMC state: “The overall goal of the Centre is to help renew public trust in science by working to promote more balanced, accurate and rational coverage of the controversial science stories that now regularly hit the headlines”, and; “…the Centre will be free of any particular agenda within science and will always strive to promote a broad spectrum of scientific opinion – especially where there are clear divisions within science. It will not shy away from promoting voices that are critical of particular aspects of science.”[i]

The ScMC have experts available for commenting on specific areas of science news. Their ‘expert’ for media comment on ME/CFS related news stories is Professor Sir Simon Wessely. Professor Wessely was a PACE Trial Centre Leader, member of the PACE Trial Management Group and collaborated in the design and execution of the research. For many years he has expressed his controversial opinion that ME/CFS are psychological illnesses that can be treated with GET and CBT. His bias is irrefutable and perpetuates to the present day. The Principal Investigators of the PACE Trial, Professors Peter White, Michael Sharpe and Trudie Chalder are all part of the ‘wessely-school’, i.e., supporters of Professor Wessely’s ideas. Professor Wessely has conducted and co-authored research into ME/CFS with all the PACE Trial Principal Investigators amounting to dozens of publications.

Therefore it was not surprising to many ME/CFS patients that media reporting of the PACE Trial was grossly biased. It is what might be expected when an organisation that promises ‘balanced’ coverage, gives an influential position to someone who is known for their bias.

It is significant that the ScMC claim:“OUR MISSION. To provide, for the benefit of the public and policymakers, accurate and evidence-based information about science and engineering through the media, particularly on controversial and headline news stories when most confusion and misinformation occurs.”[ii]

The implications of this are disturbing.The ScMC expect that information provided under their auspices will influence ‘policymakers’.

So policymakers should be able to make decisions about research, planning, purchasing and provision of medical treatments that could affect millions of patients using the ScMC’s ‘accurate and evidence-based’ information. Yet following the ScMC hosted press-conference, these media articles appeared:

As the Medical Research Council (MRC) funded the PACE Trial, it should meet the MRC Guidelines for Good Research Practice (2005) which states:“The MRC’s mission can only be fulfilled if the results of research are communicated effectively. The MRC therefore expects those it supports to play their part in disseminating balanced information on scientific advances and their potential implications for society to the health professionals and policy makers who will be involved in applying them, and to the wider public.”

False, exaggerated and selective reporting do not constitute ‘balanced information’, but may nevertheless have significant “potential implications for society to the health professionals and policy makers who will be involved in applying them, and to the wider public.”

If healthcare providers fund the treatments GET and CBT expecting 60% to improve and 30% to recover or even get close to ‘normal’ they will have been egregiously misled.

The General Medical Council state in:[i]“Good practice in research. About this guidance.

You must help to resolve uncertainties about the effects of treatments. (Paragraph 14f)

Research involving people directly or indirectly is vital in improving care and reducing uncertainty for patients now and in the future, and improving the health of the population as a whole. (Paragraph 70)

If you are involved in designing, organising or carrying out research, you must put the protection of participants’ interests first, act with honesty and integrity and follow the appropriate national research governance guidelines. (Paragraph 71)”

The MRC Good Research Practice states:[i]“G.5 When reporting research findings in publications, presenting at scientific meetings and engaging in debates in the media or in public, any relevant interests must be declared. This is to help others understand the factors that may have influenced the research team and would include any interests that might be considered by others, including the public, to be a conflict. Research findings that are likely to attract strong public or media interest should be drawn to the attention of the MRC and/or other research funders before publication.”